Free trade agreements, global manufacturing standards and the Internet have made it possible for companies to do business in countries they would not have considered twenty years ago. The world of opportunity is wide open, but for Research and Development (R&D) and Manufacturing of pharmaceuticals, semiconductors and other materials that must meet high standards of product purity and performance, the competition is stiffer than ever, as compliance with industry standards and government regulations forces companies large and small to play by the same rules. To better flex their muscles in the marketplace and pump up research and development, giant drugmakers are dismantling in-house manufacturing operations and moving production to places like China, India, Puerto Rico and Ireland, where they can take advantage of cheap land, low-cost labor, tax incentives or other perks.
The same goes for the nimble neophytes in emerging fields such as Biotechnology, biopharmaceuticals and nanotechnology; these R&D startups are outsourcing production and thus avoiding the prohibitive cost of owning and operating manufacturing facilities. A prerequisite for the manufacturing of novel products that may spend years in development pipelines is having technologically advanced manufacturing facilities.
To maintain cash flow—especially if there is no revenue base—these types of facilities must be delivered at the lowest possible cost. However, many companies, particularly those in the throes of startup and scaleup, lack experience in, or are unfamiliar with, the nuances of specifying high technology manufacturing facilities, and undertaking these projects using the traditional methods will not meet their requirements.
A methodology is needed to minimize the risk and maximize the return on investment for the delivery of high-technology facilities. Preferably, such a methodology should be applied early in the development process of a facility, such as during conception of the project, to reduce cost penalties involved in modifying a project once it is underway.